EES
Generic Name: erythromycin ethylsuccinate
Dosage Form: Granules, liquid and filmtabs
To reduce the development of drug-resistant bacteria
and maintain the effectiveness of E.E.S. and other antibacterial drugs, E.E.S.
should be used only to treat or prevent infections that are proven or strongly
suspected to be caused by bacteria.
EES Description
Erythromycin is produced by a strain of Saccharopolyspora
erythraea (formerly Streptomyces erythraeus ) and belongs to the macrolide group of antibiotics. It is basic
and readily forms salts with acids. The base, the stearate salt, and the
esters are poorly soluble in water. Erythromycin ethylsuccinate is an ester
of erythromycin suitable for oral administration. Erythromycin ethylsuccinate
is known chemically as erythromycin 2"-(ethylsuccinate). The molecular
formula is C43H75NO16 and the molecular weight
is 862.06. The structural formula is:

E.E.S. Granules are intended for reconstitution with water.
Each 5-mL teaspoonful of reconstituted cherry-flavored suspension contains
erythromycin ethylsuccinate equivalent to 200 mg of erythromycin.
The pleasant tasting, fruit-flavored liquids are supplied
ready for oral administration.
E.E.S. 200 Liquid:
Each 5-mL teaspoonful of fruit-flavored suspension contains erythromycin
ethylsuccinate equivalent to 200 mg of erythromycin.
E.E.S.
400 Liquid: Each 5-mL teaspoonful of orange-flavored suspension contains
erythromycin ethylsuccinate equivalent to 400 mg of erythromycin.
Granules and ready-made suspensions are intended primarily
for pediatric use but can also be used in adults.
E.E.S.
400® Filmtab® Tablets: Each tablet contains
erythromycin ethylsuccinate equivalent to 400 mg of erythromycin.
The Filmtab® tablets are intended primarily
for adults or older children.
Inactive Ingredients
E.E.S. 200 Liquid: FD&C Red No. 40, methylparaben,
polysorbate 60, propylparaben, sodium citrate, sucrose, water, xanthan gum
and natural and artificial flavors.
E.E.S.
400 Liquid: D&C Yellow No. 10, FD&C Yellow No. 6, methylparaben,
polysorbate 60, propylparaben, sodium citrate, sucrose, water, xanthan gum
and natural and artificial flavors.
E.E.S.
Granules: Citric acid, FD&C Red No. 3, magnesium aluminum silicate, sodium
carboxymethylcellulose, sodium citrate, sucrose and artificial flavor.
E.E.S. 400 Filmtab Tablets: Cellulosic polymers, confectioner"s
sugar (contains corn starch), corn starch, D&C Red No. 30, D&C Yellow
No. 10, FD&C Red No. 40, magnesium stearate, polacrilin potassium, polyethylene
glycol, propylene glycol, sodium citrate, sorbic acid, and titanium dioxide.
EES - Clinical Pharmacology
Orally administered erythromycin ethylsuccinate suspensions
and Filmtab tablets are readily and reliably absorbed. Comparable serum levels
of erythromycin are achieved in the fasting and nonfasting states.
Erythromycin diffuses readily into most body fluids. Only
low concentrations are normally achieved in the spinal fluid, but passage
of the drug across the blood-brain barrier increases in meningitis. In the
presence of normal hepatic function, erythromycin is concentrated in the liver
and excreted in the bile; the effect of hepatic dysfunction on excretion of
erythromycin by the liver into the bile is not known. Less than 5 percent
of the orally administered dose of erythromycin is excreted in active form
in the urine.
Erythromycin crosses the placental
barrier, but fetal plasma levels are low. The drug is excreted in human milk.
Microbiology
Erythromycin acts by inhibition of protein synthesis
by binding 50 S ribosomal subunits
of susceptible organisms. It does not affect nucleic acid synthesis. Antagonism
has been demonstrated in vitro between
erythromycin and clindamycin, lincomycin, and chloramphenicol.
Many strains of Haemophilus
influenzae are resistant to erythromycin alone but are susceptible
to erythromycin and sulfonamides used concomitantly.
Staphylocci
resistant to erythromycin may emerge during a course of therapy.
Erythromycin has been shown to be active against most strains
of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS
AND USAGE section.
Gram-positive Organisms
Corynebacterium
diphtheriae
Corynebacterium minutissimum
Listeria
monocytogenes
Staphylococcus aureus(resistant
organisms may emerge during treatment)
Streptococcus
pneumoniae
Streptococcus pyogenes
Gram-negative Organisms
Bordetella
pertussis
Legionella pneumophila
Neisseria gonorrhoeae
Other Microorganisms
Chlamydia
trachomatis
Entamoeba histolytica
Mycoplasma
pneumoniae
Treponema pallidum
Ureaplasma urealyticum
The following in vitro data are available, but their clinical significance is unknown.
Erythromycin exhibits in vitro minimal inhibitory concentrations (MIC"s)
of 0.5 μg/mL or less against most (≥ 90%) strains of the following
microorganisms; however, the safety and effectiveness of erythromycin in treating
clinical infections due to these microorganisms have not been established
in adequate and well controlled clinical trials.
Gram-positive Organisms
Viridans
group streptococci
Gram-negative Organisms
Moraxella
catarrhalis
Susceptibility Tests
Dilution Techniques
Quantitative methods are used to determine antimicrobial
minimum inhibitory concentrations (MIC"s). These MIC"s provide
estimates of the susceptibility of bacteria to antimicrobial compounds. The
MIC"s should be determined using a standardized procedure. Standardized
procedures are based on a dilution method1 (broth or agar) or equivalent
with standardized inoculum concentrations and standardized concentrations
of erythromycin powder. The MIC values should be interpreted according to
the following criteria:
| MIC (μg/mL) |
Interpretation |
| ≤ 0.5 |
Susceptible (S) |
| 1-4 |
Intermediate (I) |
| ≥ 8 |
Resistant (R) |
A report of "Susceptible" indicates that the
pathogen is likely to be inhibited if the antimicrobial compound in the blood
reaches the concentrations usually achievable. A report of "Intermediate"
indicates that the result should be considered equivocal, and, if the microorganism
is not fully susceptible to alternative, clinically feasible drugs, the test
should be repeated. This category implies possible clinical applicability
in body sites where the drug is physiologically concentrated or in situations
where high dosage of drug can be used. This category also provides a buffer
zone which prevents small uncontrolled technical factors from causing major
discrepancies in interpretation. A report of "Resistant" indicates that the
pathogen is not likely to be inhibited if the antimicrobial compound in the
blood reaches the concentrations usually achievable; other therapy should
be selected.
Standardized susceptibility
test procedures require the use of laboratory control microorganisms to control
the technical aspects of the laboratory procedures. Standard erythromycin
powder should provide the following MIC values:
| Microorganism |
MIC (μg/mL) |
|
S. aureus ATCC
25923 |
0.12-0.5 |
|
E. faecalis ATCC
29212 |
1-4 |
Diffusion Techniques
Quantitative methods that require measurement
of zone diameters also provide reproducible estimates of the susceptibility
of bacteria to antimicrobial compounds. One such standardized procedure2 requires
the use of standardized inoculum concentrations. This procedure uses paper
disks impregnated with 15-μg erythromycin to test the susceptibility
of microorganisms to erythromycin.
Reports
from the laboratory providing results of the standard single-disk susceptibility
test with a 15-μg erythromycin disk should be interpreted according
to the following criteria:
| Zone Diameter (mm) |
Interpretation |
| ≥ 23 |
Susceptible (S) |
| 14-22 |
Intermediate (I) |
| ≤ 13 |
Resistant (R) |
Interpretation should be as stated above for
results using dilution techniques. Interpretation involves correlation of
the diameter obtained in the disk test with the MIC for erythromycin.
As with standardized dilution techniques, diffusion
methods require the use of laboratory control microorganisms that are used
to control the technical aspects of the laboratory procedures. For the diffusion
technique, the 15-μg erythromycin disk should provide the following
zone diameters in these laboratory test quality control strains:
| Microorganism |
Zone Diameter (mm) |
|
S. aureus ATCC
25923 |
22-30 |
Indications and Usage for EES
To reduce the development of drug-resistant bacteria
and maintain the effectiveness of E.E.S. and other antibacterial drugs, E.E.S.
should be used only to treat or prevent infections that are proven or strongly
suspected to be caused by susceptible bacteria. When culture and susceptibility
information are available, they should be considered in selecting or modifying
antibacterial therapy. In the absence of such data, local epidemiology and
susceptibility patterns may contribute to the empiric selection of therapy.
E.E.S. is indicated in the treatment of infections caused
by susceptible strains of the designated organisms in the diseases listed
below
Upper respiratory tract infections of mild
to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae,
or Haemophilus influenzae (when used
concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin
concentrations ordinarily achieved). (See appropriate sulfonamide labeling
for prescribing information.)
Lower-respiratory
tract infections of mild to moderate severity caused by Streptococcus
pneumoniae or Streptococcus pyogenes.
Listeriosis caused by Listeria
monocytogenes.
Pertussis (whooping
cough) caused by Bordetella pertussis.
Erythromycin is effective in eliminating the organism from the nasopharynx
of infected individuals rendering them noninfectious. Some clinical studies
suggest that erythromycin may be helpful in the prophylaxis of pertussis in
exposed susceptible individuals.
Respiratory
tract infections due to Mycoplasma pneumoniae.
Skin and skin structure infections
of mild to moderate severity caused by Streptococcus
pyogenes or Staphylococcus aureus (resistant
staphylococci may emerge during treatment).
Diphtheria:
Infections due to Corynebacterium diphtheriae, as an adjunct to antitoxin, to prevent establishment of carriers
and to eradicate the organism in carriers.
Erythrasma:
In the treatment of infections due to Corynebacterium
minutissimum.
Intestinal amebiasis
caused by Entamoeba histolytica (oral
erythromycins only). Extraenteric amebiasis requires treatment with other
agents.
Acute pelvic inflammatory disease
caused by Neisseria gonorrhoeae: As
an alternative drug in treatment of acute pelvic inflammatory disease caused
by N. gonorrhoeae in female patients
with a history of sensitivity to penicillin. Patients should have a serologic
test for syphilis before receiving erythromycin as treatment of gonorrhea
and a follow-up serologic test for syphilis after 3 months.
Syphilis caused by Treponema pallidum: Erythromycin is an alternate choice of treatment for primary syphilis
in patients allergic to the penicillins. In treatment of primary syphilis,
spinal fluid examinations should be done before treatment and as part of follow-up
after therapy.
Erythromycins are indicated for
the treatment of the following infections caused by Chlamydia
trachomatis: conjunctivitis of the newborn, pneumonia of infancy,
and urogenital infections during pregnancy. When tetracyclines are contraindicated
or not tolerated, erythromycin is indicated for the treatment of uncomplicated
urethral, endocervical, or rectal infections in adults due to Chlamydia
trachomatis.
When tetracyclines are
contraindicated or not tolerated, erythromycin is indicated for the treatment
of nongonococcal urethritis caused by Ureaplasma
urealyticum.
Legionnaires" Disease
caused by Legionella pneumophila.
Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data
suggest that erythromycin may be effective in treating Legionnaires"
Disease.
Prophylaxis
Prevention of Initial Attacks of Rheumatic Fever
Penicillin is considered by the American Heart
Association to be the drug of choice in the prevention of initial attacks
of rheumatic fever (treatment of Streptococcus
pyogenes infections of the upper respiratory tract, e.g., tonsillitis
or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic
patients.3 The therapeutic dose should be administered for 10
days.
Prevention of Recurrent Attacks of Rheumatic Fever
Penicillin or sulfonamides are considered by the
American Heart Association to be the drugs of choice in the prevention of
recurrent attacks of rheumatic fever. In patients who are allergic to penicillin
and sulfonamides, oral erythromycin is recommended by the American Heart Association
in the long-term prophylaxis of streptococcal pharyngitis (for the prevention
of recurrent attacks of rheumatic fever).3
Contraindications
Erythromycin is contraindicated in patients with known
hypersensitivity to this antibiotic.
Erythromycin
is contraindicated in patients taking terfenadine, astemizole, pimozide, or
cisapride. (See PRECAUTIONS - Drug Interactions.)
Warnings
There have been reports of hepatic dysfunction, including
increased liver enzymes, and hepatocellular and/or cholestatic hepatitis,
with or without jaundice, occurring in patients receiving oral erythromycin
products.
There have been reports suggesting
that erythromycin does not reach the fetus in adequate concentration to prevent
congenital syphilis. Infants born to women treated during pregnancy with
oral erythromycin for early syphilis should be treated with an appropriate
penicillin regimen.
Pseudomembranous
colitis has been reported with nearly all antibacterial agents, including
erythromycin, and may range in severity from mild to life threatening. Therefore,
it is important to consider this diagnosis in patients who present with diarrhea
subsequent to the administration of antibacterial agents.
Treatment with antibacterial agents alters the normal flora
of the colon and may permit overgrowth of clostridia. Studies indicate that
a toxin produced by Clostridium difficile is
a primary cause of "antibiotic-associated colitis".
After
the diagnosis of pseudomembranous colitis has been established, therapeutic
measures should be initiated. Mild cases of pseudomembranous colitis usually
respond to discontinuation of the drug alone. In moderate to severe cases,consideration should be given to management with fluids and electrolytes,
protein supplementation, and treatment with an antibacterial drug clinically
effective against Clostridium difficile colitis.
Rhabdomyolysis with or without renal impairment has been reported
in seriously ill patients receiving erythromycin concomitantly with lovastatin.
Therefore, patients receiving concomitant lovastatin and erythromycin should
be carefully monitored for creatine kinase (CK) and serum transaminase levels.
(See package insert for lovastatin.)
Precautions
General
Prescribing E.E.S. in the absence of a proven or
strongly suspected bacterial infection or a prophylactic indication is unlikely
to provide benefit to the patient and increases the risk of the development
of drug-resistant bacteria.
Since erythromycin
is principally excreted by the liver, caution should be exercised when erythromycin
is administered to patients with impaired hepatic function. (See CLINICAL PHARMACOLOGY and WARNINGS sections.)
There have been reports
that erythromycin may aggravate the weakness of patients with myasthenia gravis.
There have been reports of infantile hypertrophic pyloric
stenosis (IHPS) occurring in infants following erythromycin therapy. In one
cohort of 157 newborns who were given erythromycin for pertussis prophylaxis,
seven neonates (5%) developed symptoms of non-bilious vomiting or irritability
with feeding and were subsequently diagnosed as having IHPS requiring surgical
pyloromyotomy. A possible dose-response effect was described with an absolute
risk of IHPS of 5.1% for infants who took erythromycin for 8-14 days and 10%
for infants who took erythromycin for 15-21 days.4 Since erythromycin
may be used in the treatment of conditions in infants which are associated
with significant mortality or morbidity (such as pertussis or neonatal Chlamydia trachomatis infections), the benefit
of erythromycin therapy needs to be weighed against the potential risk of
developing IHPS. Parents should be informed to contact their physician if
vomiting or irritability with feeding occurs.
Prolonged
or repeated use of erythromycin may result in an overgrowth of nonsusceptible
bacteria or fungi. If superinfection occurs, erythromycin should be discontinued
and appropriate therapy instituted.
When indicated,
incision and drainage or other surgical procedures should be performed in
conjunction with antibiotic therapy.
Information for Patients
Patients should be counseled that antibacterial
drugs including E.E.S. should only be used to treat bacterial infections.
They do not treat viral infections (e.g., the common cold). When E.E.S.
is prescribed to treat a bacterial infection, patients should be told that
although it is common to feel better early in the course of therapy, the medication
should be taken exactly as directed. Skipping doses or not completing the
full course of therapy may (1) decrease the effectiveness of the immediate
treatment and (2) increase the likelihood that bacteria will develop resistance
and will not be treatable by E.E.S. or other antibacterial drugs in the future.
Drug Interactions
Erythromycin use in patients who are receiving high
doses of theophylline may be associated with an increase in serum theophylline
levels and potential theophylline toxicity. In case of theophylline toxicity
and/or elevated serum theophylline levels, the dose of theophylline should
be reduced while the patient is receiving concomitant erythromycin therapy.
Concomitant administration of erythromycin and digoxin has
been reported to result in elevated digoxin serum levels.
There have been reports of increased anticoagulant effects
when erythromycin and oral anticoagulants were used concomitantly. Increased
anticoagulation effects due to interactions of erythromycin with various oral
anticoagulants may be more pronounced in the elderly.
Erythromycin
is a substrate and inhibitor of the 3A isoform subfamily of the cytochrome
p450 enzyme system (CYP3A). Coadministration of erythromycin and a drug primarily
metabolized by CYP3A may be associated with elevations in drug concentrations
that could increase or prolong both the therapeutic and adverse effects of
the concomitant drug. Dosage adjustments may be considered, and when possible,
serum concentrations of drugs primarily metabolized by CYP3A should be monitored
closely in patients concurrently receiving erythromycin.
The following are examples of some clinically significant CYP3A
based drug interactions. Interactions with other drugs metabolized by the
CYP3A isoform are also possible. The following CYP3A based drug interactions
have been observed with erythromycin products in post-marketing experience:
Ergotamine/dihydroergotamine
Concurrent use of erythromycin and ergotamine
or dihydroergotamine has been associated in some patients with acute ergot
toxicity characterized by severe peripheral vasospasm and dysesthesia.
Triazolobenzodiazepines (such as triazolam and alprazolam) and related
benzodiazepines
Erythromycin has been reported to decrease the
clearance of triazolam and midazolam, and thus, may increase the pharmacologic
effect of these benzodiazepines.
HMG-CoA Reductase Inhibitors
Erythromycin has been reported to increase concentrations
of HMG-CoA reductase inhibitors (e.g., lovastatin and simvastatin). Rare
reports of rhabdomyolysis have been reported in patients taking these drugs
concomitantly.
Sildenafil (Viagra)
Erythromycin has been reported to increase the
systemic exposure (AUC) of sildenafil. Reduction of sildenafil dosage should
be considered. (See Viagra package insert.)
There have been spontaneous or published reports of CYP3A
based interactions of erythromycin with cyclosporine, carbamazepine, tacrolimus,
alfentanil, disopyramide, rifabutin, quinidine, methylprednisolone, cilostazol,
vinblastine, and bromocriptine.
Concomitant
administration of erythromycin with cisapride, pimozide, astemizole, or terfenadine
is contraindicated. (See CONTRAINDICATIONS .)
In addition, there have been reports of interactions of
erythromycin with drugs not thought to be metabolized by CYP3A, including
hexobarbital, phenytoin, and valproate.
Erythromycin
has been reported to significantly alter the metabolism of the nonsedating
antihistamines terfenadine and astemizole when taken concomitantly. Rare
cases of serious cardiovascular adverse events, including electrocardiographic
QT/QTc interval prolongation, cardiac arrest, torsades de pointes,
and other ventricular arrhythmias have been observed. (See CONTRAINDICATIONS.) In addition, deaths have been reported rarely with concomitant
administration of terfenadine and erythromycin.
There
have been post-marketing reports of drug interactions when erythromycin is
co-administered with cisapride, resulting in QT prolongation, cardiac arrhythmias,
ventricular tachycardia, ventricular fibrillation, and torsades de pointes,
most likely due to inhibition of hepatic metabolism of cisapride by erythromycin.
Fatalities have been reported. (See CONTRAINDICATIONS.)
Drug/Laboratory Test Interactions
Erythromycin interferes with the fluorometric determination
of urinary catecholamines.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term (2-year) oral studies in rats with erythromycin
ethylsuccinate and erythromycin base did not provide evidence of tumorigenicity.
Mutagenicity studies have not been conducted. There was no apparent effect
on male or female fertility in rats fed erythromycin (base) at levels up to
0.25% of diet.
Pregnancy
Teratogenic Effects
Pregnancy Category B
There is no evidence of teratogenicity or any
other adverse effect on reproduction in female rats fed erythromycin base
(up to 0.25% of diet) prior to and during mating, during gestation, and through
weaning of two successive litters. There are, however, no adequate and well
controlled studies in pregnant women. Because animal reproduction studies
are not always predictive of human response, this drug should be used during
pregnancy only if clearly needed.
Labor and Delivery
The effect of erythromycin on labor and delivery
is unknown.
Nursing Mothers
Erythromycin is excreted in human milk. Caution
should be exercised when erythromycin is administered to a nursing woman.
Pediatric Use
See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION sections.
Adverse Reactions
The most frequent side effects of oral erythromycin
preparations are gastrointestinal and are dose-related. They include nausea,
vomiting, abdominal pain, diarrhea and anorexia. Symptoms of hepatitis, hepatic
dysfunction and/or abnormal liver function test results may occur. (See WARNINGS.)
Onset of
pseudomembranous colitis symptoms may occur during or after antibiotic treatment.
(See WARNINGS.)
Erythromycin
has been associated with QT prolongation and ventricular arrhythmias, including
ventricular tachycardia and torsades de pointes.
Allergic
reactions ranging from urticaria to anaphylaxis have occurred. Skin reactions
ranging from mild eruptions to erythema multiforme, Stevens-Johnson syndrome,
and toxic epidermal necrolysis have been reported rarely.
There have been rare reports of pancreatitis and convulsions.
There have been isolated reports of reversible hearing loss
occurring chiefly in patients with renal insufficiency and in patients receiving
high doses of erythromycin.
Overdosage
In case of overdosage, erythromycin should be discontinued.
Overdosage should be handled with the prompt elimination of unabsorbed drug
and all other appropriate measures should be instituted.
Erythromycin is not removed by peritoneal dialysis or hemodialysis.
EES Dosage and Administration
Erythromycin ethylsuccinate suspensions and Filmtab
tablets may be administered without regard to meals.
Children
Age, weight, and severity of the infection are important
factors in determining the proper dosage. In mild to moderate infections
the usual dosage of erythromycin ethylsuccinate for children is 30 to 50 mg/kg/day
in equally divided doses every 6 hours. For more severe infections this dosage
may be doubled. If twice-a-day dosage is desired, one-half of the total daily
dose may be given every 12 hours. Doses may also be given three times daily
by administering one-third of the total daily dose every 8 hours.
The following dosage schedule is suggested for mild to moderate
infections:
| Body Weight |
Total Daily Dose |
| Under 10 lbs |
30-50 mg/kg/day 15-25 mg/kg/q 12 h |
| 10 to 15 lbs |
200 mg |
| 16 to 25 lbs |
400 mg |
| 26 to 50 lbs |
800 mg |
| 51 to 100 lbs |
1200 mg |
| over 100 lbs |
1600 mg |
Adults
400 mg erythromycin ethylsuccinate every 6 hours
is the usual dose. Dosage may be increased up to 4 g per day according to
the severity of the infection. If twice-a-day dosage is desired, one-half
of the total daily dose may be given every 12 hours. Doses may also
be given three times daily by administering one-third of the total daily dose
every 8 hours.
For adult dosage calculation,
use a ratio of 400 mg of erythromycin activity as the ethylsuccinate to 250
mg of erythromycin activity as the stearate, base or estolate.
In the treatment of streptococcal infections, a therapeutic
dosage of erythromycin ethylsuccinate should be administered for at least
10 days. In continuous prophylaxis against recurrences of streptococcal infections
in persons with a history of rheumatic heart disease, the usual dosage is
400 mg twice a day.
For Treatment of Urethritis Due to C.
trachomatis or U. urealyticum
800 mg three times a day for 7 days.
For Treatment of Primary Syphilis
Adults: 48 to 64 g given in divided doses over
a period of 10 to 15 days.
For Intestinal Amebiasis
Adults
400 mg four times daily for 10 to 14 days.
Children
30 to 50 mg/kg/day in divided doses for 10 to 14 days.
For Use in Pertussis
Although optimal dosage and duration have not been
established, doses of erythromycin utilized in reported clinical studies were
40 to 50 mg/kg/day, given in divided doses for 5 to 14 days.
For Treatment of Legionnaires" Disease
Although optimal doses have not been established,
doses utilized in reported clinical data were those recommended above (1.6 to
4 g daily in divided doses.)
How is EES Supplied
E.E.S. 200 LIQUID (erythromycin ethylsuccinate oral
suspension, USP) is supplied in 1 pint bottles (NDC 0074-6306-16) and in 100-mL bottles (NDC 0074-6306-13).
E.E.S. 400® LIQUID
(erythromycin ethylsuccinate oral suspension, USP) is supplied in 1 pint
bottles (NDC 0074-6373-16) and in 100-mL
bottles (NDC 0074-6373-13).
Both liquid products require refrigeration to preserve taste
until dispensed. Refrigeration by patient is not required if used within
14 days.
E.E.S. GRANULES (erythromycin ethylsuccinate
for oral suspension, USP) is supplied in 100-mL (NDC 0074-6369-02) and 200-mL (NDC 0074-6369-10)
size bottles.
E.E.S. 400 Filmtab tablets (erythromycin
ethylsuccinate tablets, USP) 400 mg, are supplied as pink tablets imprinted
with the Abbott “A” logo,
and two letter Abbo-Code designation, EE, in bottles of 100 (NDC 0074-5729-13), 500 (NDC 0074-5729-53)
and 1000 (NDC 0074-5729-19) and in
ABBO-PAC unit dose strip packages of 100 (NDC 0074-5729-11).
Recommended storage
Store tablets below 86°F (30°C).
Store granules, prior to mixing, below 86°F (30°C).
After mixing, refrigerate and use within 10 days.
REFERENCES
- National Committee for Clinical Laboratory Standards, Methods
for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically, Third Edition. Approved Standard NCCLS Document M7-A3, Vol.
13, No. 25. NCCLS, Villanova, PA, December 1993.
- National Committee for Clinical Laboratory Standards, Performance
Standards for Antimicrobial Disk Susceptibility Tests, Fifth Edition.
Approved Standard NCCLS Document M2-A5, Vol. 13, No. 24. NCCLS, Villanova,
PA, December 1993.
- Committee on Rheumatic Fever, Endocarditis, and Kawasaki Disease of
the Council on Cardiovascular Disease in the Young, the American Heart Association:
Prevention of Rheumatic Fever. Circulation. 78(4):1082-1086, October 1988.
- Honein, M.A., et. al.: Infantile hypertrophic pyloric stenosis after
pertussis prophylaxis with erythromycin: a case review and cohort study.
The Lancet 1999;354 (9196):2101-5.
Filmtab—Film-sealed tablets, Abbott.
Abbott Laboratories
North Chicago, IL
60064, U.S.A.
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Revised: 06/2006